Commonly prescribed heart drug is recalled in 22 countries

A change in manufacturing process at a Chinese factory is thought to have led to some packs of valtarsan being contaminated with a carcinogenic substance

On July 5, 2018, the European Medicines Agency announced that it was reviewing products containing the API valsartan supplied by Zhejiang Huahai Pharmaceuticals in Linhai, China after N-nitrosodimethylamine (NDMA) was detected by the company.

Valsartan is an important prescription medicine used to treat high blood pressure and heart failure.

The presence of the impurity was believed to be related to changes in the manufacturing process of valsartan.

"People taking valsartan medication affected by this recall are advised to not stop taking their medication, but to speak to their doctor or healthcare professional who can advise on alternative treatment", said Dr Sam Atkinson, MHRA's Director of the Inspection, Enforcement and Standards Division.

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The HPRA says not all valsartan medicines are affected and is reassuring patients that other treatments are available. At present there is no evidence that this impurity has caused any harm to patients; however, this recall action is being undertaken as a precautionary measure to prevent any further exposure to the impurity in the affected medicines whilst the investigation is ongoing.

The MHRA said the European Medicines Agency and other EU regulators were working together to investigate the extent of the issue.

"In the last few hours the EMA sent a notification regarding a potential unexpected impurity found in the active pharmaceutical ingredient manufactured in China, and which is used in the manufacture of some Valsartan products", read the statement. "We are engaging with healthcare professionals to manage this situation".

It added that patients should not stop taking their medications abruptly.

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